Gilead Sciences, Inc. (GILD - Free Report) announced positive long-term results from the DISCOVER study of Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets, F/TAF) for pre-exposure prophylaxis (PrEP).
These data were presented at the 2020 Conference on Retroviruses and Opportunistic Infections (CROI) in Boston.
These longer-term efficacy and safety outcomes from the DISCOVER study showed that Descovy is effective for HIV prevention with non-inferior efficacy to Truvada, and that Descovy has an improved bone and renal safety profile compared with Truvada at week 96.
We note that Descovy for PrEP is indicated to reduce the risk of sexually acquired HIV-1 infection in at-risk adults and adolescents weighing at least 35 kg, excluding individuals at risk of HIV-1 from receptive vaginal sex because effectiveness in this population has not been evaluated yet.
The above-mentioned results were achieved in the overall study population of men and transgender women at risk of HIV infection as well as study sub-population of participants aged 50 and older, those younger than 25 years and those with moderate renal impairment.
Meanwhile, a separate analysis of the DISCOVER study demonstrated that Descovy and Truvada were effective and well tolerated in Black and Hispanic/Latinx participants.
In addition, Gilead announced results from a phase Ib study evaluating the company’s investigational toll-like receptor 7 (TLR7) agonist, vesatolimod, as part of an HIV cure research program. These findings mark the first clinical data showing TLR7 stimulation by vesatolimod is associated with a modestly increased time to viral rebound compared to placebo, as well as enhanced immune function and decreased levels of intact HIV DNA.
The results presented at CROI 2020 support further evaluation of vesatolimod as part of investigational curative regimens aimed at achieving antiretroviral therapy (ART)-free control of HIV.
We note that the massive decline in sales of the HCV franchise has propelled Gilead to focus on the HIV franchise, CAR T therapy and other newer avenues. The rapid adoption of Biktarvy augments the HIV business amid stiff competition from the likes of GlaxoSmithKline (GSK - Free Report) . Gilead recently announced that it will acquire a clinical-stage immuno-oncology company, Forty Seven, Inc. (FTSV - Free Report) , for $95.50 per share in cash or approximately $4.9 billion.
Gilead’s stock has gained 14.6% in the past year against the industry's decline of 10.7%.
The stock is in the news, lately, as Gilead announced the initiation of two-phase III studies to evaluate the safety and efficacy of remdesivir in adults diagnosed with COVID-19 (novel coronavirus).
These randomized, open-label, multicenter studies will enroll approximately 1,000 patients at medical centers primarily across Asian countries, as well as other countries globally with high numbers of diagnosed cases. The studies will assess two dosing durations of remdesivir, administered intravenously. The initiation of these studies follows the FDA’s rapid review and acceptance of Gilead’s investigational new drug (IND) filing for remdesivir for the treatment of COVID-19.
We note that quite a few companies are working on drugs and vaccines for the treatment coronavirus, as more and more cases are being reported every day. AbbVie’s (ABBV - Free Report) Kaletra is also being evaluated as a treatment option.
Gilead currently carries a Zacks Rank #4 (Sell). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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